Field of Invention
The present invention relates generally to medical devices. More specifically, the present invention involves a specially designed toroidal balloon that can be rolled into a place of function or away from its place of function (e.g., after use) without injuring the adjacent tissue, where the toroidal balloon is used to apply a pressure across its external surface or the surface surrounding its inner channel.
Discussion of Prior Art
Existing balloons used commonly in the medical field are designed for dilation, creation of a space, securing a device in place or application of a medical device. They are spherical or sausage-shaped when inflated. Such fixed shapes are static by nature and limit the balloon's application and utility. An example of a sausage-shaped balloon is one to dilate a ureter for insertion of a scope or removal of a urinary stone. Another example is a balloon used to dilate a stenosis involving a coronary artery and to place a coronary artery stent. In general, in such prior art systems, these balloons must be deflated during insertion and withdrawal.
Toroidal balloons have properties that have improved function, safety and utility over existing balloons. Toroidal balloons are donut-shaped and, like a ring, have an outer surface and an inner surface that surrounds the inner channel. Because of its inner channel, toroidal balloons have benefits over simple balloons. There are many examples of toroidal balloons in the prior art, wherein such toroidal balloons are generally used to dilate or to form a seal between an artificial tube and a hollow structure, as in the case of the inflatable cuff on an endotracheal tube.
The U.S. patent to Gahara (U.S. Pat. No. 5,195,970) discloses a Collapsible Balloon Catheter. The disclosed balloons and balloon catheters are used in medical dilatation procedures with particular emphasis being placed on the ability of such devices to withstand significant inflation pressures and also address problems associated with “winging” during deflation. While the disclosed balloon is used for dilation, it is static and not moveable.
The U.S. patent to Smith et al. (U.S. Pat. No. 5,632,761) discloses Inflatable Devices for Separating Layers of Tissue, and Methods of Using. The disclosed apparatus relates to inflatable tissue separation devices that are static and not moveable.
The U.S. patent application to Hahnen (US 2001/0023332 A1) discloses an Inflatable Cannula and Method of Using Same. Disclosed with in a cannula or catheter that can be introduced to a small port and be inflated to accommodate a large flow of fluids, or can serve as a conduit or port to apply other medical therapy, such as surgical instruments, dilatation catheters, atherectomy devices, filters, aspirators, and pressure monitors. In this setup, the toroidal balloon may be constructed over a catheter or tube. However, the inflatable cannula is static and not moveable.
The U.S. Patent Publication to Towler (US 2008/0086083 A1) discloses Inflatable Toroidal-Shaped Balloons. The disclosed toroidal balloon is provided with a central opening traversing the balloon in an inflated state, where the balloon is useful to achieve larger outer diameters than conventional balloons. However, as in the previous piece of prior art, the inflated balloons are static with no movement.
The U.S. Patent Publication to Huetter et al. (US 2009/0270964 A1) discloses a “Toroidal Balloon System and Method of Use.” The disclosed toroidal balloon comprises an inflatable cylinder, which compresses an outside wall and maintains a passage within it. It is important to note that, when inflated, the cylinder is static and has no capability of moving.
While the prior art above describes a toroidal balloon, such balloons are more of a donut-shape than an elongated-donut-shape, as described in this disclosure. Further, the prior art also fail to disclose any rotational movement of the toroidal balloon as described in this disclosure.
However, absent in all references described above is a toroidal balloon which, in addition to being movable, is also used for the express purpose of applying pressure along its outside or inner wall. Furthermore, also absent in such prior art is an inflatable toroidal balloon which, under pressure, allows not only the application of a biologically active substance or medical device to a biological surface adjacent to the toroidal balloon's external or internal surface, but also the option to leave the substance or device in place against the biological wall with the rotational removal of the toroidal balloon.
Whatever the precise merits, features, and advantages of the above cited references, none of them achieve or fulfill the purposes of the present invention.